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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 021802


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NDA 021802 describes FOCALIN XR, which is a drug marketed by Sandoz and is included in one NDA. It is available from two suppliers. Additional details are available on the FOCALIN XR profile page.

The generic ingredient in FOCALIN XR is dexmethylphenidate hydrochloride. There are six drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the dexmethylphenidate hydrochloride profile page.
Summary for 021802
Tradename:FOCALIN XR
Applicant:Sandoz
Ingredient:dexmethylphenidate hydrochloride
Patents:0
Pharmacology for NDA: 021802
Medical Subject Heading (MeSH) Categories for 021802
Suppliers and Packaging for NDA: 021802
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802 NDA Novartis Pharmaceuticals Corporation 0078-0430 0078-0430-05 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0078-0430-05)
FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802 NDA Novartis Pharmaceuticals Corporation 0078-0431 0078-0431-05 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0078-0431-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength5MG
Approval Date:May 26, 2005TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength10MG
Approval Date:May 26, 2005TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength20MG
Approval Date:May 26, 2005TE:ABRLD:Yes

Expired US Patents for NDA 021802

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sandoz FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-006 Aug 11, 2010 ⤷  Try a Trial ⤷  Try a Trial
Sandoz FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-002 May 26, 2005 ⤷  Try a Trial ⤷  Try a Trial
Sandoz FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-004 Aug 1, 2006 ⤷  Try a Trial ⤷  Try a Trial
Sandoz FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-006 Aug 11, 2010 ⤷  Try a Trial ⤷  Try a Trial
Sandoz FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-007 Apr 21, 2011 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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